Extension of Study ZPV-200

Repros Therapeutics

Status and phase: Completed; Phase 2

Conditions: Uterine Fibroids

Treatments: Drug: telepristone acetate 12 mg; Drug: telepristone acetate 6 mg; Drug: telepristone acetate 3 mg; Drug: telepristone acetate 24 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01631903

ZPV-200 EXT

Details and patient eligibility

About

The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18 to 47 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound. Normal, or abnormal but non-clinically significant, transvaginal ultrasound. History of menstrual events occurring in regular cycles.
• Agreement not to attempt to become pregnant.
• Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit.
• Ability to complete a daily subject diary and study procedures in compliance with the protocol.
• Agrees to use the condoms provided and no other method of birth control (hormonal methods, contraceptive sponge, spermicide or cervical cap) over the course of the study.
• Has a negative pregnancy test at the Screening and Baseline visits. An exception for the pregnancy test requirement will be granted for subjects providing verification of surgical sterilization.
• A Body Mass Index (BMI) between 18 and 39 inclusive.
• Is available for all treatment and follow-up visits.
• Subject is able to insert vaginal suppositories.
• Subject is willing to exclusively use sanitary napkins (no tampons) during study duration.

Exclusion criteria

• Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy.
• Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period.
• Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5x ULN AND total bilirubin exceeding 1.5xULN at screening and confirmed on repeat).
• Received an investigational drug in the 30 days prior to the screening for this study.
• Women with a history of PCOS.
• Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
• Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
• Has an IUD in place.
• Women currently using narcotics.
• Women currently taking cimetidine or spironolactone.
• Clinically significant abnormal findings on screening examination or any condition, which in the opinion of the investigator, would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.
• Participation in study ZP-204.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

48 participants in 5 patient groups

Arm 2 (3mg)

Experimental group

Treatment:

Drug: telepristone acetate 3 mg

Arm 3 (6 mg)

Experimental group

Treatment:

Drug: telepristone acetate 6 mg

Arm 4 (12 mg)

Experimental group

Treatment:

Drug: telepristone acetate 12 mg

Drug: telepristone acetate 12 mg

Arm 5 (24 mg)

Experimental group

Treatment:

Drug: telepristone acetate 24 mg

PK arm (12 mg)

Experimental group

Description:

PK arm requires one additional 24 hour PK assessment at V3 and daily visits between visits 2 and 3 for drug trough sample collection

Treatment:

Drug: telepristone acetate 12 mg

Drug: telepristone acetate 12 mg